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Concerns for safety
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Cervical preparation before second trimester dilation and evacuation (D&E) reduces risks and complications. Osmotic cervical dilators as well as prostaglandin analogues have been studied for cervical preparation. However, the optimal method for cervical preparation, especially for D&E procedures that occur on the same day as cervical preparation, is not known. This study will investigate misoprostol versus placebo as an adjunct to Dilapan-S for cervical preparation for same-day D&E between 16+0 and 20+6 weeks gestation.
HYPOTHESIS: Administration of 400 µg buccal misoprostol compared to placebo at least 3 hours prior to D&E as an adjunct to cervical preparation with Dilapan-S will decrease operative time for same-day D&E performed between 16+0 and 20+6 weeks.
Dilation and evacuation (D&E) is commonly performed for second trimester abortions and management of second trimester intrauterine fetal demise (IUFD). Cervical preparation prior to second trimester D&E increases safety.
Osmotic cervical dilators and prostaglandin analogs are used widely for cervical preparation before second trimester D&E. Osmotic dilators are placed into the cervical canal, radially expand as they absorb moisture and decrease the risk of cervical injury during D&E. Laminaria tents are the most commonly used osmotic dilator for D&E cervical preparation but require N18 h to reach maximum diameter. Dilapan-S®, a synthetic osmotic cervical dilator, has a significant dilation effect 2 h after placement with the majority of expansion occurring in 4-6 h according to the manufacturer.
Misoprostol is the most commonly used pharmacologic cervical preparation for D&E with duration of action between 2 and 4 h after administration. Multiple studies demonstrate the safety of misoprostol before early second trimester abortion. One prospective and four retrospective studies suggest that same-day cervical preparation with Dilapan-S and/or misoprostol for second trimester D&E through 20 weeks is safe and effective. Misoprostol may be less effective when used alone compared to overnight osmotic dilators for cervical preparation later in the second trimester but has adjunctive benefit on cervical dilation and procedure time when used with overnight osmotic dilators between 16 and 24 weeks. The effect appears most pronounced at N19 weeks gestation. No prospective studies have been published examining misoprostol as an adjunct to osmotic dilators for cervical preparation for same-day D&E.
Administration of adjunctive misoprostol with Dilapan-S has the potential to effectively prepare the cervix and decrease operative time for same-day D&E. We compared cervical preparation with Dilapan-S with and without adjunctive buccal misoprostol for same-day D&E between 16 0/7 and 20 6/7 weeks gestation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol | Experimental | Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S. |
|
| Folic Acid | Placebo Comparator | Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 400 mcg of buccal misoprostol, 3 hours prior to planned D&E |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | The primary outcome will be operative time. Operative time will be measured from initial passage of an instrument into the uterus to start the D&E. The end of operative time will be measured by the removal of the last instrument from the uterus to complete the D&E. | Day 1 of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Pain | Change in pain from baseline to immediately preoperatively using a 100-mm Visual Analogue Scale ("100-mm Visual Analogue Scale with 0 indicating "no pain" and 100 indicating "worst pain in my life") | Day 1 |
| Number of Participants With Postoperative Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator, MD MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood of Western Pennsylvania | Pittsburgh | Pennsylvania | 15213 | United States | ||
| Univeristy of Pittsburgh, Magee-Womens Hospital of UPMC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16458640 | Background | Edelman AB, Buckmaster JG, Goetsch MF, Nichols MD, Jensen JT. Cervical preparation using laminaria with adjunctive buccal misoprostol before second-trimester dilation and evacuation procedures: a randomized clinical trial. Am J Obstet Gynecol. 2006 Feb;194(2):425-30. doi: 10.1016/j.ajog.2005.08.016. | |
| 16055570 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Misoprostol | Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S. Misoprostol |
| FG001 | Folic Acid | Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S Folic Acid |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Misoprostol | Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S. Misoprostol |
| BG001 | Folic Acid | Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S Folic Acid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Operative Time | The primary outcome will be operative time. Operative time will be measured from initial passage of an instrument into the uterus to start the D&E. The end of operative time will be measured by the removal of the last instrument from the uterus to complete the D&E. | Posted | Mean | Standard Deviation | minutes | Day 1 of the study |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Misoprostol | Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage | Reproductive system and breast disorders | Systematic Assessment | Cervical laceration during dilation and evacuation procedure resulting in hemorrhage treated with uterine artery embolization |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christy Boraas, MD, MPH | University of Minnesota | 612-273-7111 | bora0021@umn.edu |
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| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Folic Acid | Drug | 4 mg of buccal folic acid, 3 hours prior to planned D&E |
|
|
Patient postoperative satisfaction with cervical preparation method |
| Day 1 |
| Number of Providers With Overall Satisfaction | Provider overall satisfaction with cervical preparation | Day 1 |
| Complications | Incidence of surgical complications related to D&E | Day 1 |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| Goldberg AB, Drey EA, Whitaker AK, Kang MS, Meckstroth KR, Darney PD. Misoprostol compared with laminaria before early second-trimester surgical abortion: a randomized trial. Obstet Gynecol. 2005 Aug;106(2):234-41. doi: 10.1097/01.AOG.0000168629.17326.00. |
| 20687085 | Background | Newmann SJ, Dalve-Endres A, Diedrich JT, Steinauer JE, Meckstroth K, Drey EA. Cervical preparation for second trimester dilation and evacuation. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007310. doi: 10.1002/14651858.CD007310.pub2. |
| 18061709 | Background | Fox MC, Hayes JL; Society of Family Planning. Cervical preparation for second-trimester surgical abortion prior to 20 weeks of gestation. Contraception. 2007 Dec;76(6):486-95. doi: 10.1016/j.contraception.2007.09.004. Epub 2007 Nov 9. |
| 21570547 | Background | Wilson LC, Meyn LA, Creinin MD. Cervical preparation for surgical abortion between 12 and 18 weeks of gestation using vaginal misoprostol and Dilapan-S. Contraception. 2011 Jun;83(6):511-6. doi: 10.1016/j.contraception.2010.10.004. Epub 2010 Dec 3. |
| 16531179 | Background | Patel A, Talmont E, Morfesis J, Pelta M, Gatter M, Momtaz MR, Piotrowski H, Cullins V; Planned Parenthood Federation of America Buccal Misoprostol Waiver Group. Adequacy and safety of buccal misoprostol for cervical preparation prior to termination of second-trimester pregnancy. Contraception. 2006 Apr;73(4):420-30. doi: 10.1016/j.contraception.2005.10.004. Epub 2006 Jan 23. |
| 27241895 | Result | Boraas CM, Achilles SL, Cremer ML, Chappell CA, Lim SE, Chen BA. Synthetic osmotic dilators with adjunctive misoprostol for same-day dilation and evacuation: a randomized controlled trial. Contraception. 2016 Nov;94(5):467-472. doi: 10.1016/j.contraception.2016.05.008. Epub 2016 May 27. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Patient Pain | Change in pain from baseline to immediately preoperatively using a 100-mm Visual Analogue Scale ("100-mm Visual Analogue Scale with 0 indicating "no pain" and 100 indicating "worst pain in my life") | Posted | Mean | Standard Deviation | mm | Day 1 |
|
|
|
|
| Secondary | Number of Participants With Postoperative Satisfaction | Patient postoperative satisfaction with cervical preparation method | Posted | Number | participants | Day 1 |
|
|
|
| Secondary | Number of Providers With Overall Satisfaction | Provider overall satisfaction with cervical preparation | Posted | Number | providers | Day 1 |
|
|
|
| Secondary | Complications | Incidence of surgical complications related to D&E | Posted | Number | participants | Day 1 |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Placebo Comparator: Folic Acid | Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S | 2 | 15 | 0 | 15 |
|
| Hemorrhage | Reproductive system and breast disorders | Systematic Assessment | Cervical laceration during dilation and evacuation procedure resulting in hemorrhage treated with hysterectomy |
|
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |